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Warning Letter

Case 586932 — FEI 1000113729

Facility

Recent inspections

  • 1149181 (VAI Thu Aug 19 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1090180 (VAI Mon May 06 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1044362 (OAI Mon Mar 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 982613 (VAI Fri Jul 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Denterprise International, Inc.
Date
October 9, 2019
Fiscal Year
2020
Product Type
Devices
Center
CDRH
Location
Ormond Beach, FL (United States)